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@BuenaVista
Question: “When did Avacta say breast cancer will be an additional focus?”
Answer: At the AGM, the question was asked about Breast Cancer. AS replied that it was a focus for Avacta, however, a second trial (Phase 1a, 1b, etc) would be expensive. Breast cancer may follow completion of AVA6000 Phase 1b or when funds or partnerships permit.
The above can be viewed towards the end of the AGM video (01:02:00 for 3 minutes) https://www.youtube.com/watch?v=DlHRRmycxTY
Hopefully that helps.
Please view the AGM video from 1:04:20 to 1:08:00
https://www.youtube.com/watch?v=DlHRRmycxTY
3 minute and 40 seconds Clip will tell you all you need to know.
Hold & GLA
05 Apr 2023: First Patient Dosed in Fifth Cohort of AVA6000 Phase Ia Dose Escalation Study https://avacta.com/first-patient-dosed-in-fifth-cohort-of-ava6000-phase-ia-dose-escalation-study/
21 Jun 2023: Successful Completion of Fifth Dose Escalation in AVA6000 Phase 1 Clinical Study https://avacta.com/successful-completion-of-fifth-dose-escalation-in-ava6000-phase-1-clinical-study/
8 weeks in to Cohort VI.
News on Cohort VI and MTD soon?
GLA
Please view the AGM video from 1:04:20 to 1:08:00
https://www.youtube.com/watch?v=DlHRRmycxTY
So much AVA6000/Dox iformation in that 3 minute and 40 seconds Clip.
Watch with a coffee before the kids get active. It Works!
GLA
@D-Geeman
Questions: “And yet they don't have accurate data for dox, after 40 years and several studies with naked dox arms for comparison. Did these studies just throw away their data, or didn't perform biopsies when they seem extremely important in the AVA6k trial? And so how do they know what a 'therapeutic level' is now?
Answers: Please view the AGM video from 1:04:20 to 1:08:00
https://www.youtube.com/watch?v=DlHRRmycxTY
The answers, and so much more, are in that 3 minute and 40 seconds Clip. Watch with a coffee before the kids get active.
It Works!
It does not have to be an acquisition.
As Dr. William Tap commented, “If we have a version of Doxorubicin (AVA6000) that works better than the current offering then, overnight, that becomes the new standard of care. Licence deal one, (£m+).
With pre|CISION™ proven, it can be used as a carrier for other toxins. More multi £m+ licencing deals.
So many opportunities.
Big Pharma’s spend Billions each year on R&D.
https://pharmaboardroom.com/articles/top-10-global-pharma-companies-2022/
In US$ Billions, Pfizer (13.8), Novartis (9), J&J (11.7), Roche (13), BMS (9.5), Merck (12.2), Sanofi (6.5), AstraZeneca (7.9), GSK (6.5). A number of these have Oncology and Cancer as a Major Objective.
The AVA6000 Phase 1a trials have demonstrated that the pre|CISION™ platform works in humans. AVA6000 is delivering Dox’ to the tumour(s) at “Significant Therapeutic Levels”. Phase 1a will continue until we have MTD, however, Avacta has suggested that while there may be a Cohort VII, Cohort VIII is unlikely. MTD is close.
We then move to Phase 1B for the initial evaluations of efficacy. We know Dox’ is being deposited in the tumour with reduced side effects so, to quote from the AGM, “why the H#ll wouldn’t it work?”
Avacta can boast a very experienced and influential Scientific and Executive team. The Avacta team has contacts throughout BIG PHARMA’s and the Medical Sector.
Avacta has over 10 years of innovative R&D, is funded, has several new products coming to market and closed, on AIM, with a Market Cap’ at UK£ 257m, (Thursday 27th July 2023).
To quote some others, it does not make sense!
Some may continue to trade in and out on a daily basis but, in my opinion, they are ignoring the significantly larger opportunity. Understanding the pain with the LTH’s, however, I still believe that Avacta is worth significantly more than the current market cap. I believe a number of the large pharma’s will see this also.
Painful now, but significant rewards will come to those who wait. I’m for waiting!
As ever GLA.
Interesting that each of these Big Pharma’s spend Billions (£/$) each year on R&D. If the R&D is done, and there are ground breaking products such as pre|CISION™, ABA6000, AVA3996, etc. What's not to like?
Avacta must be worth considerably more than the current market cap/share price.
@PAH00
The impression at the AGM was that, due to more cohorts being achieved in Phase1a, the Phase1b dosage(s), procedure(s) and time scales are being reviewed. We all have different ideas but should hopefully know more from Avacta soon.
@DTW
Phase1b:
The protocols for Phase1B are being reviewed.
Patients in Phase1b may be dosed at two levels. Some at a level below MTD and some at a higher level or MTD. If MTD proves to be too high, the levels will be dropped to the safer lower level. If MTD is shown to be safe, the patients on the lower level dose may move up to the higher dose, (MTD).
Phase1b is studying efficacy and, for the reason above, MTD is required before proceeding.
GLA
Phase1a:
Cohort V delivered Doxorubicin at x2.2 normal levels. Cohorts VI will commence early July and deliver Doxorubicin at x2.7 normal levels. There may/may not be a need for Cohort VII with Doxorubicin delivered in volumes >x3 normal levels.
Alistair stated during the on-line video presentation that:
“We are seeing therapeutically significant levels of Dox in the tumour biopsies”. To repeat, as Alistair did, “THERAPUTICALLY SIGNIFICNT LEVELS”.
Alistair goes on to say, “we know the levels of doxorubicin required to make the drug work and the levels we are seeing in the biopsies are greater. That’s what we can say factually now”. Alistair goes on to say, “Why the H*ll wouldn’t it work”?
Watch the AGM video from 1:04:25 – 1:08:50 https://www.youtube.com/watch?v=DlHRRmycxTY
Phase1b:
The protocols for Phase1B are being reviewed.
Patients in Phase1b may be dosed at two levels. Some at a level below MTD and some at a higher level or MTD. If MTD proves to be too high, the levels will be dropped to the safer lower level. If MTD is shown to be safe, the patients on the lower level dose may move up to the higher dose, (MTD).
Phase1b is studying efficacy and, for the reason above, MTD is required before proceeding.
My understanding: Phase1a proves that the pre|CISION™ platform works.
Data will be published on Phase1a, Phase1b will start and commercials discussions can also start with other pharma’s who may wish to use the pre|CISION™ platform with their own toxins. Any other toxins will required their own clinical trial.
After Phase1a, there may be opportunities for commercials deals.
AVA6000 is using a combination of pre|CISION™ and Doxorubicin to offer chemotherapy treatments with greater dosing in the tumour and reduced side effects. An absolutely magnificent scientific achievement.
AstraZeneca (AZN) is developing a new drug (Datopotamab Deruxtacan) for the treatment of Lung Cancer. Analysts believe that this new drug could generate as much as £14.2bn in sales. There has been a number of Grade 5 events (deaths) during the clinical trials. The Grade 5 events have delayed the clinical trials and resulted in the AZN share price dropping from £112.80 to £103.74 (down 8% or £12.5bn) last week.
Avacta: During the recent AGM, it was confirmed that the AVA6000 Phase1a clinical trials are delivering “SIGNIFICANT THERAPUTIC LEVELS” of Doxorubicin in the tumour sites. It was also confirmed that we have not yet reached MTD and the Doxorubicin side effects are greatly reduced.
Conclusion: The pre|CISION™ platform works.
Opportunity: There are many pharma’s, such as AZN above, with therapeutic products which are restricted due to their toxicities and side effects, (Grade 5 deaths). These companies may be able to use the pre|CISION™ platform to bring their therapeutic products to market and, potentially, save many lives.
AZN release bad news about the Datopotamab Deruxtacan clinical trials and their market cap drops £12.5bn or 8% in one week.
What is pre|CISION™ worth to a major pharma such as AZN?
Does make me wonder, …….
GLA